Data from Novartis COMFORT-II
European Phase III trial show treatment with ruxolitinib provided a
statistically significant reduction in spleen size in patients with
myelofibrosis when compared with best available therapy

Myelofibrosis is a debilitating
disease with a poor prognosis and limited therapies, presenting a
critical unmet medical need

US New Drug Application submission
by Incyte and EU Marketing Authorization Application submission by
Novartis on track for Q2 2011

Complete data to be submitted by
Novartis to an upcoming medical meeting

WILMINGTON, Del.--(BUSINESS WIRE)--Mar 15, 2011 - COMFORT-II,
the second pivotal Phase III trial of Incyte Corporation's (Nasdaq:
INCY) investigational Janus kinase (JAK) inhibitor, ruxolitinib
(INCB18424 or INC424), has met its primary endpoint of
significantly reducing spleen size in patients with myelofibrosis
(MF), when compared to best available therapy. This trial was
conducted by Novartis as part of the Incyte-Novartis worldwide
collaboration and license agreement for ruxolitinib, an oral JAK1
and JAK2 inhibitor.

The European study, called COMFORT-II (COntrolled MyeloFibrosis Study
with ORal JAK Inhibitor Therapy), showed treatment with ruxolitinib
provided a statistically significant reduction in spleen size in
patients with primary MF, post-polycythemia vera myelofibrosis
(PPV-MF), or post-essential thrombocythemia myelofibrosis (PET-MF),
when compared with best available therapy, administered at doses
and schedules determined by the investigator. The safety profile of
ruxolitinib was consistent with previous studies. Complete study
data will be submitted to an upcoming medical meeting.

“The positive results from the European COMFORT-II trial
confirm the data from the US trials and further strengthen our
confidence that ruxolitinib has the potential to provide
myelofibrosis patients, and the physicians who treat them, a new
approach to effectively manage this debilitating, life-threatening
disease,” stated Paul Friedman, M.D. President and CEO of
Incyte. “We and Novartis will continue to work diligently to
bring ruxolitinib forward as the first JAK1 and JAK2 inhibitor
available to treat MF.”

Data from the COMFORT-II and COMFORT-I clinical trials will form
the basis of worldwide regulatory filings, planned to begin in the
second quarter of 2011, first in the US followed by the EU. Both
the European Commission (EC) and the United States Food and Drug
Administration (FDA) have granted ruxolitinib orphan drug status
for MF.

“The COMFORT-I and II trials constitute the largest
clinical trial program to date in myelofibrosis. Data from these
two Phase III trials demonstrate how treatment with ruxolitinib was
more effective than placebo and any other available medical
therapies,” said Richard Levy, M.D., Executive Vice President
and Chief Drug Development and Medical Officer of Incyte. “It
is also very gratifying to see that the COMFORT-II safety profile
is consistent with the previous studies.”

About COMFORT-II

COMFORT-II is a randomized, open-label Phase III study of
ruxolitinib (also known as INCB18424 or INC424) versus best
available therapy that enrolled 219 patients with primary MF,
PPV-MF or PET-MF in 56 study locations in Europe. Two-thirds
received ruxolitinib and one-third received best available therapy,
administered at doses and schedules determined by the investigator.
The primary endpoint for COMFORT-II is the proportion of patients
achieving a reduction in spleen volume of 35% or more from baseline
to week 48 as measured by MRI (or CT scan in applicable patients).
Reduction of spleen size is an accepted measurement for clinical
improvement in MF1,2. COMFORT-II is sponsored by
Novartis5.

About Myelofibrosis (MF)

MF is an uncommon, life-threatening blood cancer characterized
by bone marrow failure, enlarged spleen (splenomegaly),
debilitating symptoms including fatigue, night sweats and pruritus,
poor quality of life, and weight loss, as well as shortened
survival2. MF is one of the Philadelphia
chromosome-negative myeloproliferative neoplasms (MPNs) which also
includes polycythemia vera and essential thrombocythemia. Of the
JAK-associated MPNs, MF carries the greatest risk of a poor
prognosis, including transformation to fatal acute myelogenous
leukemia, and there are currently no approved treatments for MF in
the US2,3. Although allogeneic stem cell transplantation
may cure MF, the procedure is associated with significant morbidity
and mortality and is usually appropriate only in younger
patients4.

About Ruxolitinib (INCB18424)

Ruxolitinib is Incyte's lead internally developed JAK1 and JAK2
inhibitor that entered Phase I clinical testing in May 2007 and has
shown clinical activity in a number of hematology and inflammatory
conditions. The compound recently completed a Phase III program in
myelofibrosis and is currently in a global Phase III registration
trial, RESPONSE, in patients suffering from advanced polycythemia
vera and a Phase II trial in patients with acute leukemias.
Additional clinical studies evaluating ruxolitinib in other
hematologic cancers and malignant diseases such as lymphoma and
pancreatic cancer are planned for 2011.

Forward-Looking Statements

Except for the historical information contained herein, the
matters set forth in this press release, including statements
regarding a US New Drug Application submission by Incyte and the EU
Marketing Authorization Application submission by Novartis for
ruxolitinib being on track for second quarter 2011, that complete
data will be submitted to an upcoming medical meeting, that the
positive results from the European COMFORT-II trial confirm the
data from the US trials and further strengthen our confidence that
ruxolitinib has the potential to provide myelofibrosis patients,
and the physicians who treat them, a new approach to effectively
manage this debilitating, life-threatening disease, and that Incyte
and Novartis will continue to work diligently to bring ruxolitinib
forward as the first JAK1 and JAK2 inhibitor available to treat MF,
are all forward-looking statements within the meaning of the "safe
harbor" provisions of the Private Securities Litigation Reform Act
of 1995.

These forward-looking statements are subject to risks and
uncertainties that may cause actual results to differ materially,
including the high degree of risk and uncertainty associated with
drug development and clinical trials, unanticipated developments in
the efficacy or safety of or unanticipated additional clinical
trial results for ruxolitinib, the possibility that regulatory
authorities may require additional clinical trials in order to
support registration of ruxolitinib in any particular indication,
the possibility that there may be other interpretations of the data
produced in one or more of the clinical trials for ruxolitinib, the
risk that regulatory authorities will require more extensive data
for the ruxolitinib NDA filing than currently expected, future
competitive or other market factors that may adversely affect the
commercial potential for ruxolitinib, the results of further
research and development, and other risks detailed from time to
time in Incyte's filings with the Securities and Exchange
Commission, including its Annual Report on Form 10-K for the year
ended December 31, 2010. Incyte disclaims any intent or obligation
to update these forward-looking statements.

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About Incyte

Incyte Corporation is a Wilmington, Delaware-based drug
discovery and development company focused on developing proprietary
small molecule drugs for oncology and inflammation. For additional
information on Incyte, visit the Company's web site at
www.incyte.com.

2. Tefferi A, Barosi G, Mesa RA, et al. International Working
Group (IWG) consensus criteria for treatment response in
myelofibrosis with myeloid metaplasia, for the IWG for
Myelofibrosis Research and Treatment (IWG-MRT). Blood.
2006;108:1497-1503.

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